Archive for March 29, 2012

I heard a few sentences about this on the radio this morning and I just about fell on the floor:

Artificial Knee via DJOGlobal.eu

Dangerous medical devices

Most medical implants have never been tested for safety

Tens of millions of Americans live with medical devices implanted in their bodies—artificial joints, heart defibrillators, surgical mesh. And it’s a safe bet that most of them assume that someone, somewhere, tested the devices for safety and effectiveness.

But that is rarely the case. For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and pay the Food and Drug Administration a user fee of roughly $4,000 to start selling a product that can rack up many millions of dollars in revenue. Often, the only safety “testing” that occurs is in the bodies of unsuspecting patients—including two of the three people whose stories are told in this report.

As for the smaller number of high-risk products for which advance safety studies are required, government rules allow them to be sold based on studies that are smaller and less rigorous than those required for prescription drugs.

“Standards for devices exist, they just don’t make sense,” says Diana Zuckerman, Ph.D., a vocal critic of the current system and president of the National Research Center for Women & Families, a nonprofit advocacy organization.

I find this absolutely shocking. I had no idea it was this bad. Devices implanted in people’s bodies, including those that literally keep people alive, like heart defibrillators, aren’t tested for safety?! Gosh. I wonder that came to pass (here’s lookin’ at you, lobbyists for the corporatocracy).

A widely used crop pesticide first introduced in the 1990s has caused significant changes to bee colonies worldwide and removing it could be the key factor in restoring nature’s army of pollinators, according to two studies released Thursday.

The scientists behind the studies called for regulators to consider banning the class of chemicals known as neonicotinoid [nicotine-based] insecticides. In the U.S., the Environmental Protection Agency told msnbc.com that the studies would be incorporated into a review that’s currently underway.

A pesticide trade group immediately questioned the data, saying the levels of pesticide used were unrealistic, while the researchers said the levels used were typical of what bees would find on farms.

“Our study raises important issues regarding pesticide authorization procedures,” stated Mikael Henry, co-author of a study on honey bees. “So far, they mostly require manufacturers to ensure that doses encountered on the field do not kill bees, but they basically ignore the consequences of doses that do not kill them but may cause behavioral difficulties.”

“There is an urgent need to develop alternatives to the widespread use of neonicotinoid pesticides on flowering crops wherever possible,” added the authors of the second study on bumble bees.

Following France and Germany, last year the Italian Agriculture Ministry suspended the use of a class of pesticides, nicotine-based neonicotinoids, as a “precautionary measure.” The compelling results – restored bee populations – prompted the government to uphold the ban. Yesterday, copies of the film ‘Nicotine Bees’ were delivered to the US Congress explaining the pesticide’s connection to Colony Collapse Disorder.

So, while this is big news here, it’s old news across the pond and we’re no where near suspending the use of neonicotinoid pesticides yet. Yeah! We’re No. 1! We’re No. 1! USA, USA, USA!

I didn’t mention this yesterday, but in his interview with meabout the limiting principle, former Reagan Solicitor General Charles Fried was scaldingly critical of the willingness of the conservative bloc of Supreme Court justices to traffic in some of the most well-worn Tea Party tropes about Obamacare.

“I was appalled to see that at least a couple of them were repeating the most tendentious of the Tea Party type arguments,” Fried said. “I even heard about broccoli. The whole broccoli argument is beneath contempt. To hear it come from the bench was depressing.”

[…]

Keep in mind: Many observers, Obama officials included, spent weeks treating Scalia like a potential swing vote on the case. Lawyers defending the law wrote some of their briefs and opinions with an eye towards persuading Scalia. They consciously invoked Scalia’s own words from a 2005 opinion affirming Congress’s power to control local medical marijuana in hopes it signaled he might be open to the administration’s defense of the individual mandate.

This now looks like a terrible misjudgment. During oral arguments this week, Scalia invoked the broccoli argument to question the goverment’s case. He mocked the government’s position with a reference to the “cornhusker kickback,” even though that’s not in the law. As Fried notes, this language is straight out of the Tea Party guerrilla manual that was written during the battle to prevent Obamacare from becoming law in the first place.

All of which is to say that the law’s proponents were badly caught off guard by the depth of the conservative bloc’s apparent hostility towards the law and its willingness to embrace the hard right’s arguments against its constitutionality. They didn’t anticipate that this could shape up as an ideological death struggle over the heart and soul of the Obama presidency.